# FDA 483 - MYA International, Inc - September 10, 2021

Source: https://www.globalkeysolutions.net/records/483/mya-international-inc/9749893d-60a4-4380-8ec3-618dbf3c1f9b

> FDA 483 for MYA International, Inc on September 10, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MYA International, Inc
- Inspection Date: 2021-09-10
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: MYA International, Inc. in Chula Vista, CA, received a Form 483 with six observations during an inspection of its dietary supplement manufacturing facility. The firm failed to establish specifications for both components and finished dietary supplements, did not adequately qualify suppliers, and maintained incomplete or missing batch production records. Additionally, processing equipment was not properly identified, leading to unidentified contents in a capsule filling machine.

## Related Officers

- [Lilly O Barton](https://www.globalkeysolutions.net/people/lilly-o-barton/2f6eabce-479e-4336-a0b6-34b7a5e78d99)

Company: https://www.globalkeysolutions.net/companies/mya-international-inc/e0fef8e7-61b5-4634-8a4e-849c7b72ea8e

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6